Research Project
9466154
ABSTRACT Metactive Medical is developing the Ballstent Microcatheter?, an innovative medical device for the endovascular embolic treatment of cerebral aneurysms, which are a common cause of stroke. The key component of the device is the Ballstent, an expandable, detachable, gold metal balloon that can be pleated and folded at the distal end of a delivery microcatheter, advanced into an aneurysm sac over a guidewire, expanded, positioned to occlude the aneurysm neck, and held in place by standard embolic coils that are delivered through the guidewire lumen of the device into the aneurysm sac behind the expanded Ballstent. The device is then electrolytically detached from the delivery microcatheter. This combined Ballstent and coils approach enables the treatment of a wide range of aneurysm shapes and sizes since the Ballstent is sized to the diameter of the aneurysm neck while the coils are used fill in the remainder of the sac. A pilot preclinical study with the Ballstent Microcatheter in a well-accepted, large, wide neck, venous pouch, terminal carotid artery aneurysm model in canines demonstrated immediate and complete aneurysm occlusion after treatment, which was maintained out to 28 days. When compared to the Ballstent and coils treatment, the use of coils alone required 17 devices to fill the aneurysm sac and could not completely occlude the aneurysm, either acutely or 28 days later. Wide neck sidewall aneurysms have been successfully treated with the Ballstent and coils approach as well. The objective of the proposed Phase I program is to demonstrate that the treatment of wide-neck bifurcation and sidewall aneurysms with Ballstent and coils is superior to coils only, flow diverting stents, and intrasaccular flow diverters in acute and chronic aneurysm occlusion. The research also aims to demonstrate non-inferiority of the Ballstent and coils approach on important safety measures including aneurysm rupture during treatment and thromboembolic events. Based upon the success of Phase I, a Phase II program will complete verification & validation of the final Ballstent Microcatheter design in several sizes and prepare for a first-in-human clinical trial.
